Certified Biostimulant – How to Apply

Please follow the steps below to complete the Certified Biostimulant application. The Certified Biostimulant is aligned with requirements found in Attachment 1. United States Biostimulant Industry Recommended Guidelines to Support Efficacy, Composition, and Safety of Plant Biostimulant Products. TFI strongly recommends applicants become familiar with the provisions of the Guidelines to provide the necessary information for the Certified Biostimulant application.

The application consists of an online questionnaire with prompts to upload your supporting documents. There are 5 parts:

  1. General Information
  2. Efficacy Testing Methods
  3. Composition
  4. Safety
  5. Confidential Statement and Attestation

The online application will ensure you have included all necessary elements and documents for a complete application. There are several documents that will need to be uploaded throughout the online application. Please have these documents prepared prior to starting the application.

Steps for application submission:

1. Prepare documents needed for online application

Efficacy Testing Methods

Peer-reviewed literature:

  1. Published Research Table – Attachment 2
  2. Peer-reviewed literature*

Original/internal research:

  1. Written Research Report – Attachment 3

*Published literature should demonstrate trials are randomized and replicated, have appropriate controls, and proper statistical analysis according to the U.S. Standard. Missing information in the published literature will require additional information to be submitted.

Composition

  1. Beneficial Substances Label – Attachment 4 & Attachment 6
  2. Conformance Testing Report – Attachment 5
  3. Methods for identification of the guaranteed substance (must be a recognized method)

 

Safety

  1. Safety Data Sheet
  2. Statement for the Presumption of Safety – Attachment 7 & Attachment 8

 

2. Fill out online application to submit materials

Follow application prompts and upload documents from Step 1. The application contains the following sections: General Information, Efficacy Testing Methods, Composition, Safety, and Confidential Statement and Attestation. Application questions are available for review: Attachment 9

Certified Biostimulant Application

Fill out this form to receive a personalized link for your Certified Biostimulant application.

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3. Submit payment for application

Ensure payment is submitted to accompany your application. The application will be considered “submitted” when both the application and payment have been received. You can pay the application fee here.

Other information to aid in application:

List of Attachments (referenced above)

  1. United States Biostimulant Industry Recommended Guidelines to Support Efficacy, Composition, and Safety of Plant Biostimulant Products
  2. [Published] United States Biostimulant Industry Recommended Guidelines to Support Efficacy, Composition, and Safety of Plant Biostimulant Products
  3. Published Research Table
  4. Guidelines for Written Research Report
  5. Example of the Beneficial Substances Label
  6. Sample Conformance Testing Report
  7. Example Guidelines to support product composition
  8. Safety Assessment Decision Tree
  9. Sample Statement of Rationale for the Presumption of Safety
  10. Copy of Online Application Questionnaire

Helpful sections of the guidelines:

  1. Efficacy Testing Methods – Guidelines Section I, pages 8 – 11.
  2. Composition – Guidelines Section II, pages 11 – 14
  3. Safety – Guidelines Section III, pages 14 – 19

Details on Requirements for evidence:

Applicants are required to submit proof regarding product efficacy testing methods, composition, and safety claims.

  • Efficacy testing methods: TFI developed an efficacy testing methods requirements based on the U.S. Biostimulant Standards. Applicants declare evidence based on published literature or original research.
    • Published papers must be peer-reviewed and validate that the product in the application is equivalent to the products tested in the literature. If published papers are missing key information that is specified in the U.S. Standards as a requirement, additional information should be submitted with the published literature.
    • Original research should include materials, methods, results, and discussion details, with data tables and figures.
  • Composition: The proof of composition claims that Applicants need to provide are: 1) Identify and list all beneficial substances, including the ingredient source, if applicable, 2) Support product composition with listing guaranteed substances, the minimum amount of the guaranteed substance(s) in the final product, and the method(s) for identification of the guaranteed substance(s), and 3) demonstrate the absence of contaminants such as heavy metal contaminants, microbial pathogens and other microbial contaminants.
  • Safety: Assessing human health and environmentalsafety claims are demonstrated by submitting a safety data sheet, reporting safety risks for extracts, acids, minerals, and other substances or living microorganisms, and providing a Certificate of Analysis documenting the absence of harmful contaminants.